Aztreonam Injection
- Brand(s)
- Azactam
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- E.R. Squibb & Sons, L.L.C. (2013-06-17)
- Oldest Current Product
- 2009-06-01
- License(s)
- NDA, ANDA
- RxNORM
- INJECTION\AZTREONAM
- FDAOB
- INJECTION\INJECTION\AZTREONAM\rdfq
- SPL Active
- INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\AZTREONAM
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AZTREONAM - SPL Moiety
- INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\AZTREONAM
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AZTREONAM
product(s) by strength(s)
aztreonam 1000 mg injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000032560 | Azactam | NDA | E.R. Squibb & Sons, L.L.C. | 2010-04-01 | AZTREONAM | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | NDA050580 | 9a105eaf-ee77-4016-beeb-d425a5565db2 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 633230401 | ANDA | App Pharmaceuticals, Llc | 2009-11-05 | AZTREONAM | INTRAMUSCULAR | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA065439 | 302fd27d-0a22-44ea-91fb-1b1ffcf17a1f, 5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18, c6cf7e13-a04e-47e2-9cec-44a278ee6bec |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 551541054 | Azactam | NDA | Cardinal Health | 2009-06-01 | AZTREONAM | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | 514790041 | NDA050580 | d598f95b-92dd-4ef5-ae97-d68972258e44 |
aztreonam 2000 mg injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000032570 | Azactam | NDA | E.R. Squibb & Sons, L.L.C. | 2010-04-01 | AZTREONAM | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | NDA050580 | 9a105eaf-ee77-4016-beeb-d425a5565db2 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 633230402 | ANDA | App Pharmaceuticals, Llc | 2009-11-05 | AZTREONAM | INTRAMUSCULAR | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA065439 | 302fd27d-0a22-44ea-91fb-1b1ffcf17a1f, 5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18, c6cf7e13-a04e-47e2-9cec-44a278ee6bec |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | ANDA065286 | AZTREONAM | EUROHEALTH INTERNATIONAL SARL | 2011-03-23 | ANDA065286_001, ANDA065286_002 |
| 2 | ANDA065439 | AZTREONAM | FRESENIUS KABI USA LLC | 2010-06-18 | ANDA065439_001, ANDA065439_002, ANDA065439_003 |
| 3 | NDA050580 | AZACTAM | BRISTOL MYERS SQUIBB | 1986-12-31 | NDA050580_001, NDA050580_002, NDA050580_003 |
| 4 | NDA050632 | AZACTAM IN PLASTIC CONTAINER | BRISTOL MYERS SQUIBB CO | 1989-05-24 | NDA050632_001, NDA050632_002, NDA050632_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA065286_001 | RX | AZTREONAM (1GM/VIAL) | INJECTION | False | AP | 2011-03-23 | AZTREONAM |
| 2 | ANDA065286_002 | RX | AZTREONAM (2GM/VIAL) | INJECTION | False | AP | 2011-03-23 | AZTREONAM |
| 3 | ANDA065439_001 | RX | AZTREONAM (500MG/VIAL) | INJECTION | False | 2010-06-18 | AZTREONAM | |
| 4 | ANDA065439_002 | RX | AZTREONAM (1GM/VIAL) | INJECTION | False | AP | 2010-06-18 | AZTREONAM |
| 5 | ANDA065439_003 | RX | AZTREONAM (2GM/VIAL) | INJECTION | False | AP | 2010-06-18 | AZTREONAM |
| 6 | NDA050580_001 | discontinued | AZTREONAM (500MG/VIAL) | INJECTION | False | 1986-12-31 | AZACTAM | |
| 7 | NDA050580_002 | RX | AZTREONAM (1GM/VIAL) | INJECTION | True | AP | 1986-12-31 | AZACTAM |
| 8 | NDA050580_003 | RX | AZTREONAM (2GM/VIAL) | INJECTION | True | AP | 1986-12-31 | AZACTAM |
| 9 | NDA050632_001 | RX | AZTREONAM (40MG/ML) | INJECTION | True | 1989-05-24 | AZACTAM IN PLASTIC CONTAINER | |
| 10 | NDA050632_002 | RX | AZTREONAM (20MG/ML) | INJECTION | True | 1989-05-24 | AZACTAM IN PLASTIC CONTAINER | |
| 11 | NDA050632_003 | discontinued | AZTREONAM (10MG/ML) | INJECTION | False | 1989-05-24 | AZACTAM IN PLASTIC CONTAINER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 1b11750e-4db4-4dd3-8b21-c9917b00aeaa (view SPL) | AZACTAM (aztreonam injection)in GALAXY Plastic Container (PL 2040) for Intravenous Use | prescription | Human Prescription | E.R. Squibb & Sons, L.L.C. | 2013-06-17 | 5 | 000032230, 000032240 | |
| 2 | 302fd27d-0a22-44ea-91fb-1b1ffcf17a1f (view SPL) | Aztreonam for Injection USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2015-03-02 | 1 | 633230401, 633230402 |
| 3 | 5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18 (view SPL) | Aztreonam for Injection USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2015-06-23 | 2 | 633230401, 633230402 |
| 4 | 9a105eaf-ee77-4016-beeb-d425a5565db2 (view SPL) | AZACTAM (aztreonam for injection, USP) | prescription | Human Prescription | E.R. Squibb & Sons, L.L.C. | 2013-06-17 | 3 | 000032560, 000032570 | |
| 5 | c6cf7e13-a04e-47e2-9cec-44a278ee6bec (view SPL) | Aztreonam for Injection USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2015-03-02 | 4 | 633230401, 633230402 |
| 6 | d598f95b-92dd-4ef5-ae97-d68972258e44 (view SPL) | AZACTAM (aztreonam for injection, USP) | prescription | Human Prescription | Cardinal Health | REPACK | 2012-05-07 | 1 | 551541054 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII